Trial · NCT03604198
Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome
NCT03604198, Phase 2, Active not recruiting, Corcept Therapeutics
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome. Trials, record NCT03604198. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03604198
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome
- NCT number
- NCT03604198
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 125 participants, actual
- Lead sponsor
- Corcept Therapeutics
- Conditions
- Cushing Syndrome
- Interventions
- relacorilant
- First posted
- 2018-07-27
- Last updated
- 2026-11-03
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Long-term safety of relacorilant | 36 months | Number of patients with treatment-emergent adverse events (TEAEs) as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0 or higher |
| Other | Number of patients with one or more hematology laboratory abnormality by severity grade | Up to Month 99 | The hematology laboratory abnormalities to be assessed are hemoglobin decreased, hemoglobin increased, platelet count decreased, white blood cell count decreased, leukocytosis, eosinophilia, lymphocyte count decreased, lymphocyte count increased, neutrophil count decreased. The laboratory abnormalities will be reported by worst grade of mild, moderate, severe, or life-threatening, using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE, version 4 or higher) criteria. |
| Other | Number of patients with one or more clinical chemistry laboratory abnormality by severity grade | Up to Month 99 | The clinical chemistry laboratory abnormalities to be assessed are hypoalbuminemia, alkaline phosphatase increased, alanine aminotransferase increased, aspartate aminotransferase increased, hypocalcemia, hypercalcemia, creatine increased, hypoglycemia, hyperglycemia, blood lactate dehydrogenase increased, hypomagnesemia, hypermagnesemia, hypokalemia, hyperkalemia, hyponatremia, hypernatremia, creatine phosphokinase increased, blood bilirubin increased, and hyperuricemia. The laboratory abnormalities will be reported by worst grade of mild, moderate, severe, or life-threatening, using the CTCAE, version 4 or higher criteria. |
| Other | Change from Baseline in oral body temperature | Baseline and up to Month 99 | |
| Other | Change from Baseline in respiratory rate | Baseline and up to Month 99 | |
| Other | Change from Baseline in blood pressure | Baseline and up to Month 99 | Systolic and diastolic blood pressure will be assessed. |
| Other | Change from Baseline in heart rate | Baseline and up to Month 99 | |
| Other | Change from Baseline in electrocardiogram (ECG) parameters | Baseline and Month 3 | 12-lead ECGs will be performed in duplicate and will be evaluated by a central reviewer. The parameters to be assessed are PR interval, QRS interval, QT interval, RR interval, QTcF interval, and QTcB interval. |
| Other | Change from Baseline in ECG ventricular rate | Baseline and Month 3 | 12-lead ECGs will be performed in duplicate and will be evaluated by a central reviewer. |
| Other | Change from Baseline in the longest vertical diameter of pituitary tumors as determined with magnetic resonance imaging (MRI) | Baseline and up to Month 72 | Pituitary MRI imaging will be used to assess changes in tumor size during dosing. A computed tomography (CT) scan can be used in patients for whom MRI is contraindicated. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03604198
GET https://conductscience.org/api/trials/v1/NCT03604198/registered